2009 – Federal Register Recent Federal Regulation Documents

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for permits to conduct certain activities with endangered species and/or marine mammals. Both the Endangered Species Act and the Marine Mammal Protection Act require that we invite public comment on these permit applications.

The United States Patent and Trademark Office (USPTO) has prepared interim examination instructions for evaluating patent subject matter eligibility under 35 U.S.C. 101 (Interim Patent Subject Matter Eligibility Examination Instructions) pending a decision by the U.S. Supreme Court in Bilski v. Kappos. The Interim Patent Subject Matter Eligibility Examination Instructions will be for use by USPTO personnel in their review of patent applications to determine whether the claims in a patent application are directed to patent eligible subject matter under 35 U.S.C. 101. The USPTO is requesting comments from the public regarding the Interim Patent Subject Matter Eligibility Examination Instructions.

NOAA issues this notice to inform the public that an ROD has been approved for replacement of the Southwest Fisheries Science Center (SWFSC) at the Scripps Institution of Oceanography (SIO) within the University of California at San Diego (UCSD) campus in La Jolla, California. NOAA signed the ROD on August 20, 2009.

We, the National Marine Fisheries Service (NMFS) are issuing this notice to advise the public that NMFS is adding an additional public meeting regarding proposed regulations under the Endangered Species Act and Marine Mammal Protection Act to prohibit vessels from approaching killer whales within 200 yards and from parking in the path of whales for vessels in inland waters of Washington State. The proposed regulations would also prohibit vessels from entering a conservation area during a defined season. The proposed rule was published July 29, 2009, and includes information on two public meetings. We are issuing this notice to announce a third public meeting in Anacortes, WA that has been added in response to requests for additional public meetings to allow for greater public participation.

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the collection and the estimated burden and cost.

This notice announces the intent of EPA to establish a Chesapeake Bay-wide Total Maximum Daily Load (TMDL) for nutrients and sediment for all impaired segments in the tidal portion of the Chesapeake Bay watershed. This action is being taken pursuant to section 303(d) of the Clean Water Act (CWA). To provide information to the public regarding the process, approach and implications of this action, EPA will hold a series of public meetings in late 2009 on dates and in locations to be determined. A second public comment period will be held in the summer of 2010 once a draft Chesapeake Bay TMDL is developed. This TMDL is being developed consistent with the requirements of two Consent Decrees settling the following lawsuits: American Canoe Association, Inc. and the American Littoral Society v. EPA, Civil No. 98-979-A (E.D. Va) and Kingman Park Civic Association, et al. v. U.S. Environmental Protection Agency, et al., No. 1:98CV00758 (D.D.C.). By this notice, EPA is soliciting preliminary input from the public on its plans for developing this Chesapeake Bay TMDL. EPA requests that the public provide to EPA any water quality related data and information that may be relevant to the development and calculation of the Chesapeake Bay TMDL by December 18, 2009. EPA will review all data and information submitted during the public comment period and will consider them in the development of the TMDL as appropriate.

The FDIC is adopting a final rule amending its deposit insurance regulations to: Reflect Congress's extension, until December 31, 2013, of the temporary increase in the standard maximum deposit insurance amount (``SMDIA'') from $100,000 to $250,000; finalize the interim rule, with minor modifications, on revocable trust accounts; and finalize the interim rule on mortgage servicing accounts. The FDIC is also adopting technical, conforming amendments to its international banking regulations to substitute several existing references to ``$100,000'' with references to the SMDIA.

Under the provisions of section 10[d] of the Federal Advisory Committee Act of 1972, Public Law 92-463, it is hereby determined that every Wage Committee meeting concerns matters listed in 5 U.S.C. 552b[c][2] and 5 U.S.C. 552b[c][4], and that, accordingly, the meeting will be closed to the public. The DoD announces that the Department of Defense Wage Committee will meet in September, October, November and December 2009.

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with Maran, Inc., containing a civil penalty of $50,000.00.

The following Water Management Plans are available for review:

DOT intends to establish systems of records under the Privacy Act of 1974.

This document proposes to revise the Federal regulations on the Procedures for Abatement of Highway Traffic Noise and Construction Noise. The FHWA seeks to clarify certain definitions, the applicability of this regulation, certain analysis requirements, and the use of Federal funds for noise abatement measures. In addition, the proposed regulation would include a screening tool and the latest state of the

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.

Section 17.101 of Title 38 of the Code of Federal Regulations sets forth the Department of Veterans Affairs (VA) medical regulations concerning ``Reasonable Charges'' for medical care or services provided or furnished by VA to a veteran:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.

The Food and Drug Administration (FDA) is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls (CMC)) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. Because the deadline for requests to participate in the pilot is being extended, FDA is also extending the application submission deadlines. FDA is also announcing an increase in the number of original applications being accepted into the pilot program.